Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): (PRESIDEX)

April 19, 2016 updated by: James Martin, University of Mississippi Medical Center

Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): A Randomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery.

This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or steroid will receive standard therapy to include magnesium sulfate, blood pressure medications and diuretics. We hypothesize that the addition of dexamethasone to standard therapy will accelerate CNS recovery more quickly than standard management without dexamethasone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

30 eclamptic patients who do not require steroids for fetal lung maturation purposes will be randomized to placebo or steroid. This includes patients with eclampsia encountered antepartum prior to 23 weeks gestation, postpartum eclampsia, undelivered patients encountered after 33 weeks gestation who would not be candidates for fetal lung maturation steroids, or patients not eligible for repeat steroid administration in the 23-34 week gestational window. Planned enrollment in this pilot study is up to 30 patients with at least 12 in each group.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Currently 34 weeks pregnant or within 6 weeks postpartum
  2. At least 18 years of age
  3. Singleton or twin gestation
  4. Patient or family sign informed consent
  5. Diagnosis of eclampsia
  6. Able to obtain MRI scanning within 24hours of hosp admit and/or seizure

Exclusion Criteria:

  1. Neither pregnant nor within first 6 weeks postpartum
  2. Patient or family unable to sign informed consent
  3. Less than 18 years of age
  4. Triplet or higher order gestation
  5. Unable to obtain MRI scanning within 24 hours of hospital admission (
  6. Diagnosis of cerebral hemorrhage
  7. Patient in whom MRI is contraindicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dexamethasone
Dexamethasone 12 mg, 2 doses, 12 hours apart.
Drug: Dexamethasone
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
Other Names:
  • Potent glucocorticoid or steroid
PLACEBO_COMPARATOR: Placebo
Placebo, 2 doses, 12 hours apart
Drug: Dexamethasone
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
Other Names:
  • Potent glucocorticoid or steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery
Time Frame: 36 months
To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: James Martin, MD, University of Mississippi Medican Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (ESTIMATE)

January 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 26, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0269

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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